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Home Industry News Roche study shows benefits of haemophilia A therapy Hemlibra

Roche study shows benefits of haemophilia A therapy Hemlibra

23rd November 2017

Roche has announced the findings of a new phase III clinical trial demonstrating the benefits offered by its drug Hemlibra to adults and adolescents with haemophilia A.

Results from the phase III HAVEN 3 study assessed the performance of Hemlibra among patients without inhibitors to factor VIII, and showed that the drug delivered a statistically significant and clinically meaningful reduction in the number of treated bleeds over time.

The study also met key secondary endpoints, with once-weekly Hemlibra prophylaxis shown to be superior to factor VIII prophylaxis. The most common adverse events with Hemlibra were injection site reactions, with no new safety signals observed.

Data from the HAVEN 3 study will be submitted to health authorities around the world for approval consideration, with the results also adding to a growing body of evidence showing that Hemlibra can benefit all people with haemophilia A, regardless of their inhibitor status.

Dr Sandra Horning, Roche's chief medical officer and head of global product development at Roche, said: "We look forward to working with health authorities to make this treatment available for all people with haemophilia A as soon as possible."

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